PMA supplement
P980035 S013: MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE
FDA PMA supplement · Panel Track · Medtronic, Inc.
Key facts
| Original PMA | P980035 |
|---|---|
| Supplement number | S013 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE |
| Generic name | Pulse generator, permanent, implantable |
| Applicant | Medtronic, Inc. |
| Product code | NVZ |
| Received date | Sep 17, 2001 |
| Decision date | Mar 26, 2003 |
| Docket number | 03M-0190 |
| Notice date | May 9, 2003 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: